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雷迪帕韦/索磷布韦方案治疗慢性丙型肝炎感染:来自美国工作生产力经济模型的见解。

Ledipasvir/sofosbuvir regimens for chronic hepatitis C infection: Insights from a work productivity economic model from the United States.

机构信息

Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA; Center for Outcomes Research in Liver Diseases, Washington, DC.

出版信息

Hepatology. 2015 May;61(5):1471-8. doi: 10.1002/hep.27757. Epub 2015 Mar 23.

DOI:10.1002/hep.27757
PMID:25706754
Abstract

UNLABELLED

Patients with chronic hepatitis C (CHC) exhibit reduced work productivity owing to their disease. Historically, most regimens indicated for CHC genotype 1 (GT1) patients were administered with pegylated interferon (Peg-IFN) and/or ribavirin (RBV), which further compromised work productivity during treatment. The aim of this study was to model the impact of LDV/SOF (ledipasvir/sofosbuvir), the first Peg-IFN- and RBV-free regimen for CHC GT1 patients, on work productivity from an economic perspective, compared to receiving no treatment. The WPAI-SHP (Work Productivity and Activity Index-Specific Health Problem) questionnaire was administered to patients across the ION clinical trials (N = 1,923 U.S. patients). Before initiation of treatment, patients with CHC GT1 in the ION trials exhibited absenteeism and presenteeism impairments of 2.57% and 7.58%, respectively. Patients with cirrhosis exhibited greater work productivity impairment than patients without cirrhosis. In total, 93.21% of U.S. patients in the ION trials achieved SVR; these patients exhibited absenteeism and presenteeism impairments of 2.62% (P = 0.76, when compared to baseline) and 3.53% (P < 0.0001), respectively. Monetizing these data to the entire U.S. population, our model projects an annual societal cost of $7.1 billion owing to productivity loss in untreated GT1 CHC patients. Our model projects that, when compared to no treatment, treating all CHC GT1 patients with a regimen with very high viral eradication rates (LDV/SOF) would translate to annual productivity loss savings of $2.7 billion over a 1-year time horizon.

CONCLUSIONS

Patients with untreated HCV impose a substantial societal burden owing to reduced work productivity. As a result of improvements in work productivity, treatment of CHC GT1 patients with LDV/SOF-based regimens is likely to result in significant cost savings from a societal perspective, relative to no treatment.

摘要

目的

本研究旨在从经济角度,通过模型模拟 LDV/SOF(来迪派韦索磷布韦)对慢性丙型肝炎病毒(HCV)基因型 1(GT1)患者工作生产力的影响,该药物为首个无聚乙二醇干扰素(Peg-IFN)和/或利巴韦林(RBV)的 HCV GT1 患者治疗方案,与不治疗进行比较。方法:通过 ION 临床试验(N = 1923 名美国患者)向患者发放 WPAI-SHP(工作生产力和活动指数-特定健康问题)调查问卷。在开始治疗前,ION 试验中 GT1 型 CHC 患者的缺勤率和现患率分别为 2.57%和 7.58%。有肝硬化的患者比没有肝硬化的患者工作生产力受损更严重。总的来说,ION 试验中 93.21%的美国患者达到 SVR;这些患者的缺勤率和现患率分别为 2.62%(与基线相比,P = 0.76)和 3.53%(P < 0.0001)。将这些数据货币化到整个美国人群,我们的模型预测由于未治疗的 GT1 CHC 患者生产力下降,每年会造成 71 亿美元的社会成本。我们的模型预测,与不治疗相比,在 1 年的时间内,用非常高的病毒清除率(LDV/SOF)的方案治疗所有 GT1 CHC 患者,将每年节省 27 亿美元的生产力损失。结论:未治疗的 HCV 患者由于工作生产力下降,给社会带来了巨大的负担。由于工作生产力的提高,从社会角度来看,用 LDV/SOF 为基础的方案治疗 GT1 CHC 患者,与不治疗相比,可能会带来显著的成本节约。

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